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Behavioral Training App for Children with Behavioral Challenges

This study is testing a behavioral training app for children aged 6-12 who experience behavioral challenges, including disruptive behavior, executive dysfunction (difficulty with planning and self-control), attention-deficit, and anxiety. The study aims to see if the "Treatment App" helps improve these behaviors compared to a "Sham app" (a placebo app). Success will be measured by changes in behavior ratings from parents using scales like the IOWA Conners Rating Scale and the Disruptive Behavior Disorders (DBD) Rating Scale. You or your child might be eligible if your child is between 6-12 years old, has elevated scores on a behavior questionnaire, and you are a fluent English speaker with full custody. The study plans to enroll 100 families.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to either the Treatment App or the Sham app. Participants will not know which app they are using until after the study is complete. The study plans to enroll 100 families.
What's involved
Participants will use an app for 8 weeks. Behavior will be measured before starting, throughout the 8-week intervention, and at 4 and 8 weeks after starting the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks after starting the intervention, with assessments at 4 and 8 weeks.

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NCT06447909

Randomized Controlled Trial of a Behavioral Training App

UNKNOWN
NAAges 6–12InterventionalTreatment
New York University
~100 participants
Updated 2024-06-07 on ClinicalTrials.gov
What's tested:Treatment AppSham app

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IOWA Conners Rating Scale
Measured over before starting the intervention, throughout the 8 week intervention
+2 more outcomes measured

Conditions

Behavior, Child
Disruptive Behavior
Executive Dysfunction
Attention-deficit
Anxiety
Depression
Stress

Explore related trials

Problem behavior

NCT06447909

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • New York University

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anil Chacko, PhD · PRINCIPAL_INVESTIGATOR · New York University

Who to contact

Anil Chacko, PhD
[email protected]
(212) 998-5749
Email the study team

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Eligibility criteria

Inclusion

the child must be between the ages of 6-12 at the time of baseline/pre-intervention data collection
the child must have an elevated score based on the strengths and Difficulties Questionnaire (SDQ)
the parent/caregiver must be a fluent English speaker
the parent/caregiver must be the legal guardians of and have full-time custody/child care responsibilities for their child (parents/caregiver with limited contact with their child will not have the opportunity to sufficiently use the app with their child)
the parent/caregiver must have reliable and stable mobile internet access
the parent/caregiver must use an Apple iOS operating system (the research version of the app will only be available in iOS) on their phone
the parent/caregiver and their child must reside in the United States.

Exclusion

the child or parent/caregiver presents with emergency psychiatric needs that require services beyond those that can be managed within this intervention format (e.g., hospitalization, specialized placement outside the home); In this case, an active intervention by research staff to secure what is needed will be made
if the child has an elevated score for Autism Spectrum Disorder (ASD) on the Developmental Behavior Checklist-Autism Screening Algorithm and the parent indicates that their child was diagnosed with autism or another pervasive developmental disorder;
if the parent/caregiver is currently enrolled or has recently enrolled in any type of behavioral therapy program (i.e., within the past six months)
the caregiver has used the Joon app in the past. If the child is currently taking medication, families that participate in the study will be asked to keep their child's medication status stable and report changes immediately to the project director.
Additionally, participants may be removed from the study if their child's symptoms worsen considerably such that the child requires more immediate professional intervention.

What this trial measures

  • IOWA Conners Rating Scalebefore starting the intervention, throughout the 8 week intervention

    The IOWA-CRS (Waschbusch \& Willoughby, 2008) is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. The IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3).

  • The Disruptive Behavior Disorders (DBD) Rating Scale (Pelham et al., 1992)before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention

    The DBD scale consists of 23 items from the full 45-item measure that asks parents to rate symptoms of ADHD, ODD, and CD on a 4-point Likert scale (i.e., "not at all", "just a little", "pretty much", or "very much"), with higher scores indicating more problems. For this study, the average scores for ADHD, ODD and CD will be used. Support for the scale's reliability and validity have been reported in past samples, with acceptable levels of internal consistency (.82) and concurrent correlations with other measures used for diagnosis of ADHD and ODD being reported (Pelham et al., 2005).

  • Impairment Rating Scale - Parent/Teacher Version (IRS) (Pelham, Fabiano, & Massetti, 2005)before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention

    The IRS is a multidimensional measure that assesses functioning across domains. Specifically, the IRS qualifies and quantifies impairment present in a child's life, both in school and non-school settings. The scale has parent and teacher versions that ask about the degree to which the child has problems that warrant treatment, intervention, or special services in specific areas of functioning. For children ages 4 through 12, the IRS has shown good psychometric properties and has empirically derived cutoff points. The IRS asks the informant to respond using a 7-point scale that ranges from "No problem; definitely does not need treatment or special services'' to "Extreme problem; definitely needs treatment or special services." The IRS exhibits concurrent, discriminant, and convergent validity, and acceptable levels of temporal stability.